JP2016172021A - Spine stabilization devices and methods with six degrees of freedom of motion - Google Patents
Spine stabilization devices and methods with six degrees of freedom of motion Download PDFInfo
- Publication number
- JP2016172021A JP2016172021A JP2016093785A JP2016093785A JP2016172021A JP 2016172021 A JP2016172021 A JP 2016172021A JP 2016093785 A JP2016093785 A JP 2016093785A JP 2016093785 A JP2016093785 A JP 2016093785A JP 2016172021 A JP2016172021 A JP 2016172021A
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- bone
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Landscapes
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- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Abstract
Description
〔技術分野〕
本発明は、手術または外傷後、自然な運動学的特色を保存しながら、脊椎の隣接する椎骨を安定させることに関する。
〔Technical field〕
The present invention relates to stabilizing adjacent vertebrae of the spine while preserving natural kinematic features after surgery or trauma.
〔背景技術〕
椎間デバイスは、脊椎の疾患または障害に対処する、あるいは外傷による損傷に対処するために使用される。これらのデバイスは、例えば、体重を支承しながら、隣接する椎骨の移動を安定させる、誘導する、また制限するように動作可能である。
[Background Technology]
Intervertebral devices are used to address spinal diseases or disorders, or to deal with trauma damage. These devices are operable, for example, to stabilize, guide and limit the movement of adjacent vertebrae while bearing weight.
椎間板は、外傷、疾患、変性性欠陥、または長期間にわたる摩耗によって、変位また損傷され得る。椎間板ヘルニアは、線維輪が、弱化または裂傷され、髄核の内側組織が、その正常な内部線維輪領域から外へ、恒久的に膨隆、膨張、または押出される時に生じる。脱出または「滑脱」した髄核組織の質量は、脊椎神経を圧迫し、脚部の疼痛、筋肉制御の損失、または麻痺さえもたらす可能性がある。あるいは、椎間板変性によって、髄核は、その水結合能力を喪失し、空気がタイヤから放出したように、収縮する。続いて、髄核の高さが減少し、積層された層が、弛緩した状態で結合された区域内において、線維輪を座屈させる。線維輪のこれらの重複する積層された層が、座屈を開始し、分離するにつれて、円周方向または半径方向いずれかの環状裂傷を引き起こし、持続的または動けないほどの背痛の一因となり得る。隣接する随伴脊椎面関節もまた、騎乗位置へと付勢され、付加的背痛をもたらし得る。 Intervertebral discs can be displaced or damaged by trauma, disease, degenerative defects, or prolonged wear. Intervertebral hernia occurs when the annulus fibrosus is weakened or lacerated and the inner nucleus tissue is permanently bulged, expanded, or extruded out of its normal inner annulus area. The mass of nucleus pulposus tissue that has escaped or “slided” can compress the spinal nerve, resulting in pain in the legs, loss of muscle control, or even paralysis. Alternatively, due to intervertebral disc degeneration, the nucleus pulposus loses its water binding ability and contracts as air is released from the tire. Subsequently, the nucleus pulposus height is reduced and the laminated layers buckle the annulus within the relaxed bonded area. As these overlapping laminated layers of the annulus fibrosus begin to buckle and separate, they cause either circumferential or radial annular lacerations that contribute to persistent or immobile back pain. obtain. Adjacent companion spinal joints can also be biased to the riding position, resulting in additional back pain.
髄核組織が、脱出される、または手術によって除去されると、必ず、椎間板腔は、狭小化し、その正常な安定性の大部分を喪失し得る。多くの場合、変性または脱出した椎間板からの背痛を緩和するために、髄核は、除去され、2つの隣接する椎骨が、手術によって、ともに融合される。本治療は、疼痛を緩和するが、あらゆる椎間板の運動は、融合された区画では、喪失される。最終的には、本手技は、運動の欠如を補償するにつれて、融合された区画に隣接する椎間板により大きな応力を課し、可能性として、それらの隣接する椎間板の早期変性につながる。 Whenever nucleus pulposus tissue is prolapsed or removed by surgery, the disc space can narrow and lose much of its normal stability. Often, to relieve back pain from degenerated or prolapsed discs, the nucleus pulposus is removed and two adjacent vertebrae are fused together by surgery. This treatment relieves pain, but any disc movement is lost in the fused compartment. Ultimately, as the procedure compensates for the lack of movement, it places more stress on the discs adjacent to the fused compartment, potentially leading to premature degeneration of those adjacent discs.
椎骨融合の代替として、種々の人工椎間板が、開発されてきた。初期の人工装具は、ボール軸受、バネ、金属スパイク、および他の知覚される補助等、多種多様な構想を具現化した。これらの人工装具はすべて、椎間板腔全体を置換するように作製され、大型かつ剛性である。人工椎間板のための現在の設計の多くは、大型かつ非可撓性である。加えて、人工椎間板サイズおよび他のパラメータは、外科医が、デバイスを埋め込むために講じ得るアプローチを制限する。 Various artificial discs have been developed as alternatives to vertebral fusion. Early prostheses embodied a wide variety of concepts such as ball bearings, springs, metal spikes, and other perceived aids. All of these prostheses are made to replace the entire disc space and are large and rigid. Many of the current designs for artificial discs are large and inflexible. In addition, the artificial disc size and other parameters limit the approaches that surgeons can take to implant the device.
自然な椎間板の運動を模倣する、新規椎間板の必要性が存在する。 There is a need for new discs that mimic the natural disc movement.
〔発明の概要〕
本発明による、移植片は、可撓性コアと、コアの第1の係合表面に接触するように動作可能である第1の支持構成要素と、コアの第2の反対の係合表面に接触するように動作可能である第2の支持構成要素とを含む。
[Summary of the Invention]
In accordance with the present invention, an implant includes a flexible core, a first support component operable to contact the first engagement surface of the core, and a second opposite engagement surface of the core. And a second support component operable to contact.
本発明の移植片は、隣接する椎骨等、関節の隣接する骨間に位置付けられると、関節を安定させるように動作可能である。移植片はさらに、治療上の運動範囲を越える移動を制限しながら、関節の自然な運動学的移動を可能にする。 The implant of the present invention is operable to stabilize a joint when positioned between adjacent bones of a joint, such as adjacent vertebrae. The implant further allows for natural kinematic movement of the joint while limiting movement beyond the therapeutic range of motion.
可撓性コアは、より可撓性の折曲領域を具備し、コアの反対の係合表面の変位または配向変更を可能にする。一実施形態では、コアは、一端において、先細となり、折曲領域を形成し、変形または座屈し、係合表面の相対的角変位を可能にし得る。 The flexible core has a more flexible bending area to allow displacement or reorientation of the opposite engaging surface of the core. In one embodiment, the core may taper at one end to form a folded region, deform or buckle, and allow relative angular displacement of the engagement surface.
加えて、コアは、第1の係合表面と第2の係合表面との部分間の距離を縮小するように圧縮してもよい。圧縮は、コアの内部に対して外向きに材料の拡張を含んでもよく、またはコアの材料は、内部に圧潰してもよい。 In addition, the core may be compressed to reduce the distance between portions of the first engagement surface and the second engagement surface. Compression may include expansion of the material outwardly relative to the interior of the core, or the core material may be crushed inside.
テザー、すなわち、引綱が、提供され、コアおよび第1および第2の支持構成要素の一方また両方の最大変位を制限するように動作可能であってもよい。引綱は、コアおよび支持構成要素の一方または両方のいずれかのうちの2つに添着される。引綱は、移植片の意図された運動範囲内において、移動を妨害しないように、可撓性材料から形成され、有利にも、弾性材料から形成され、進行の限界における、突然の相対的移動停止を回避してもよい。 A tether, or towline, may be provided and operable to limit the maximum displacement of the core and one or both of the first and second support components. The towline is attached to two of either the core and / or support component. The towline is formed from a flexible material, advantageously formed from an elastic material, so as not to impede movement within the intended range of movement of the graft, and sudden abrupt movement stop at the limit of travel May be avoided.
各支持構成要素は、コア係合表面および骨係合表面を有する、係合板を含む。竜骨または他の突起が、骨係合表面から延在し、骨表面、例えば、椎骨の内部部分に係合するように動作可能である。突起は、骨内部成長表面、領域、または空間を含み、さらに、板を骨と係合状態に固着させてもよい。第1および第2の支持構成要素のコア係合表面は、有利にも、コアに対する摺動または回転が意図される場合、コアの係合表面の表面材料に対して潤滑材料で形成される。 Each support component includes an engagement plate having a core engagement surface and a bone engagement surface. A keel or other protrusion extends from the bone engaging surface and is operable to engage a bone surface, eg, an internal portion of a vertebra. The protrusion includes a bone ingrowth surface, region, or space, and may secure the plate in engagement with the bone. The core engagement surfaces of the first and second support components are advantageously formed of a lubricating material relative to the surface material of the core engagement surface when sliding or rotation with respect to the core is intended.
一実施形態では、コアの折曲領域は、係合表面に近接する点において、最も可撓性である。中空内部が含まれ、その中に、折曲領域を形成する材料が偏向され得る、空間を提供するように動作可能であってもよい。コア係合表面は、平滑な表面を具備し、その上を可撓性コアの第2の係合表面が、摺動し得る。 In one embodiment, the folded region of the core is most flexible in that it is proximate to the engagement surface. A hollow interior may be included and operable to provide a space in which the material forming the folded region may be deflected. The core engagement surface comprises a smooth surface on which the second engagement surface of the flexible core can slide.
骨、例えば、関節の対向する骨の相対移動は、本発明の移植片が埋め込まれる、患者の動きから生じる。第1および第2の支持構成要素は、これらの骨に取着されるため、対応する運動が、支持構成要素内で誘発される。患者の自然な体では、これらの骨は、6運動自由度に従って動く。これらの運動自由度はそれぞれ、図4を参照して、以下のように、本発明の埋め込まれた移植片によって可能とされる。 The relative movement of the bone, eg, the opposing bone of the joint, results from the movement of the patient in which the implant of the invention is implanted. As the first and second support components are attached to these bones, corresponding movements are induced in the support components. In the patient's natural body, these bones move according to six degrees of freedom of movement. Each of these degrees of freedom of movement is enabled by the implanted implant of the present invention as follows with reference to FIG.
(1)係合表面に沿って摺動するコアに対応する、線「X」によって示される方向における平行移動
(2)コアの軸方向圧縮に対応する、線「Y」によって示される方向における平行移動
(3)係合表面に沿って摺動するコアに対応する、線「Z」によって示される方向における平行移動
(4)コアの片側の圧縮に対応する、線「X」によって示される軸を中心とした回転
(5)係合表面上を回転するコアに対応する、線「Y」によって示される軸を中心とした回転
(6)コアの片側の圧縮に対応する、線「Z」によって示される軸を中心とした回転
換言すると、移植片の軸が、本発明の移植片を通して、第1の隣接する骨から第2の隣接する骨に延在するように画定される場合、移植片は、以下に関して、隣接する第1の骨と第2の骨との相対移動を可能にすることになる。
(1) Translation in the direction indicated by line “X” corresponding to the core sliding along the engagement surface (2) Parallel in the direction indicated by line “Y” corresponding to axial compression of the core Translation (3) Translation in the direction indicated by line “Z” corresponding to the core sliding along the engagement surface (4) The axis indicated by line “X” corresponding to compression on one side of the core Rotation around the center (5) Rotation around the axis indicated by the line “Y” corresponding to the core rotating on the engagement surface (6) Indicated by the line “Z” corresponding to compression on one side of the core In other words, if the implant axis is defined to extend from the first adjacent bone to the second adjacent bone through the implant of the present invention, the implant is , Adjacent first bone and second bone with respect to It would allow movement relative.
(a)軸を中心とした対向する回転
(b)軸方向屈曲
(c)軸方向圧縮、および
(d)軸に対する半径方向摺動
代替実施形態では、コアは、実質的に、隣接する区画より狭小である、折曲領域によって分離される、第1および第2の区画を含み、したがって、区画およびその関連付けられた係合表面の角変位を可能にするように屈曲する。
(A) Opposing rotation about an axis (b) Axial bending (c) Axial compression, and (d) Radial sliding relative to the axis In an alternative embodiment, the core is substantially Narrow, including first and second compartments separated by a folded region, and thus bend to allow angular displacement of the compartment and its associated engagement surface.
本発明の一実施形態では、支持構成要素の少なくとも一部は、コアの嵌合領域に摺動可能に係合する、湾曲平滑表面として構成される、コア係合表面を有する。コア係合表面の湾曲摺動可能部分は、支持構成要素内で陥凹され、係合表面の嵌合摺動可能部分は、コアから突出する。代替として、コア係合表面は、突出されてもよく、コアの係合表面は、陥凹されてもよい。 In one embodiment of the present invention, at least a portion of the support component has a core engaging surface configured as a curved smooth surface that slidably engages the mating region of the core. The curved slidable portion of the core engaging surface is recessed in the support component, and the mating slidable portion of the engaging surface protrudes from the core. Alternatively, the core engagement surface may be protruded and the core engagement surface may be recessed.
同様に、コアの両側が、湾曲されてもよく、各側は、支持構成要素の湾曲表面と嵌合可能であって、例えば、2つの凸状表面を形成する。コアの両側の嵌合表面は、例えば、所望の運動学的移動を助長し、予期された運動範囲を通して、所望の靭帯張力を維持するように動作可能である。しかしながら、本発明によると、両表面は、患者の治療上の必要性に応じて、凸状、凹状、または平坦のいずれかであってもよいことを理解されたい。使用時、湾曲嵌合表面を伴う構成は、前述のように、全6運動自由度を可能にするが、しかしながら、嵌合湾曲摺動可能係合表面のため、付加的方向安定性が提供される。 Similarly, both sides of the core may be curved, each side being matable with the curved surface of the support component, for example forming two convex surfaces. The mating surfaces on both sides of the core are operable, for example, to facilitate the desired kinematic movement and maintain the desired ligament tension throughout the expected range of motion. However, it should be understood that, according to the present invention, both surfaces may be either convex, concave, or flat, depending on the patient's therapeutic needs. In use, the configuration with a curved mating surface, as described above, allows for a total of six degrees of freedom of movement, however, because of the mating curved slidable engaging surface, additional directional stability is provided. The
さらなる実施形態では、コアは、第2の係合表面に、支持構成要素の平坦コア係合表面に嵌合するように接続可能である、平坦表面を具備する。1つ以上のピンが、コアおよび支持構成要素内に提供されるピンボアまたは開口を通して通過し、2つの構成要素を一緒に係止する。加えて、コアの陥凹部分および突出部分と支持構成要素との間のスナップ嵌着係合がさらに、コアと支持構成要素とを一緒に固着させるように提供されてもよい。 In a further embodiment, the core comprises a flat surface that is connectable to the second engagement surface to mate with the flat core engagement surface of the support component. One or more pins pass through a pin bore or opening provided in the core and support component to lock the two components together. In addition, a recessed portion of the core and a snap fit engagement between the protruding portion and the support component may be further provided to secure the core and the support component together.
本発明のさらに別の実施形態では、コア係合表面は、コアの嵌合部分の湾曲部分より大きい波形を有する、湾曲部分を有する。したがって、コアは、支持構成要素に対して摺動し得る。コアは、同時に、回転され、均等にまたは側方に圧縮されてもよい。 In yet another embodiment of the present invention, the core engagement surface has a curved portion that has a corrugation greater than the curved portion of the mating portion of the core. Thus, the core can slide relative to the support component. The core may be simultaneously rotated and evenly or laterally compressed.
コアの嵌合表面および支持構成要素は、凹状、凸状、半球状、または樽状形状を含んでもよく、それによって、摺動、枢動、回転、揺動、または他の相対移動に対する抵抗は、全方向において均一であってもよく、または特定の方向において異なってもよい。 The mating surface and support component of the core may include a concave, convex, hemispherical, or barrel shape so that it is resistant to sliding, pivoting, rotating, swinging, or other relative movement. May be uniform in all directions or different in a particular direction.
本発明は、例えば、頸椎椎間板置換術の置換または安定化のための関節置換術用移植片を提供するが、他の関節、例えば、指、手、手首、肘、肩、脊椎の他の領域、臀部、膝、足首、足、または足指の1つ以上の関節が、部分的にまたは完全に、移植片によって置換されてもよい。 The present invention provides joint replacement implants for replacement or stabilization of, for example, cervical disc replacement, but other joints such as fingers, hands, wrists, elbows, shoulders, other areas of the spine One or more joints of the hip, knee, ankle, foot, or toe may be partially or completely replaced by the implant.
本発明の移植片は、特に、椎間板に関するが、上記に詳細されるように、全6運動自由度において、移動を呈する、全関節に関して、自然な運動学的特色および自然な関節特性を復元するように動作可能である。 The implant of the present invention relates specifically to the intervertebral disc, but as detailed above, restores natural kinematic features and natural joint properties for all joints that exhibit movement in all six degrees of freedom of movement. Is operable.
移植片の全要素は、可撓性材料から作製され得るが、コアは、特に、第1および第2の支持構成要素の角変位に対応するために撓曲する。関節が、撓曲または伸展されるにつれて、コアの可撓性および/または弾性材料は、膨隆または伸張し、対向する係合表面の角変位を可能にしてもよい。加えて、または代替として、折曲領域は、コアの比較的に脆弱な領域を提供し、厚さおよび/または形状を通して、コアの屈曲を容易にするように適合される。 All elements of the implant can be made from a flexible material, but the core in particular bends to accommodate the angular displacement of the first and second support components. As the joint is flexed or extended, the core's flexible and / or elastic material may bulge or stretch, allowing angular displacement of the opposing engagement surfaces. Additionally or alternatively, the folded region provides a relatively fragile region of the core and is adapted to facilitate bending of the core through thickness and / or shape.
移植片は、デバイスが埋め込まれるべき期間の間、患者のために、十分な強度、可撓性、弾性、および耐久性を有する、任意の生体適合性の当業者に公知の材料を使用して組み立てられてもよい。 The implant is made of any biocompatible material known to those skilled in the art that has sufficient strength, flexibility, elasticity, and durability for the patient during the period in which the device is to be implanted. May be assembled.
本発明によると、単一移植片が使用され、弱化した関節または関節部分のために、安定化を提供してもよい。代替として、2つ、3つ、またはそれ以上の移植片が、単一関節レベルにおいて、または複数の関節内で使用されてもよい。さらに、本発明の移植片は、他の安定化手段と組み合わせられてもよい。 According to the present invention, a single implant may be used to provide stabilization for weakened joints or joint portions. Alternatively, two, three, or more implants may be used at the single joint level or within multiple joints. Furthermore, the implant of the present invention may be combined with other stabilizing means.
本発明の任意の表面または構成要素は、当業者に公知の方法を使用して、治療的割合で放出され得る、骨成長、治癒、抗菌性、または薬物材料を含む、治療薬でコーティングされてもよく、あるいはそれによって含浸されてもよい。 Any surface or component of the present invention is coated with a therapeutic agent, including bone growth, healing, antibacterial, or drug material that can be released at therapeutic rates using methods known to those skilled in the art. Or may be impregnated thereby.
〔図面の簡単な説明〕
本発明、ならびにその付帯利点および特徴のより完全な理解は、付随の図面と併せて検討される時、以下の発明を実施するための形態を参照することによって、より容易に理解されるであろう。
〔図1〕本発明による、移植片の斜視図を描写する。
〔図2〕移植片の骨係合突起を通して、中心から切り取られた図1の移植片の断面を図示する。
〔図3〕体内の2つの隣接する骨間に位置付けられる、図1の移植片を図示する。
〔図4〕図1の移植片を図示しており、線は、移植片の運動自由度を示す。
〔図5〕本発明の移植片の別の実施形態の斜視分解図を描写する。
〔図6〕移植片の骨係合突起を通して、中心から切り取られた図5の移植片の断面を図示する。
〔図7〕本発明の移植片のさらなる実施形態の斜視分解図を描写する。
〔図8〕移植片の骨係合突起を通して、中心から切り取られた図7の移植片の断面を図示する。
[Brief description of the drawings]
A more complete understanding of the present invention, and its attendant advantages and features, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings. Let's go.
FIG. 1 depicts a perspective view of an implant according to the present invention.
FIG. 2 illustrates a cross section of the implant of FIG. 1 taken from the center through the bone engaging protrusion of the implant.
FIG. 3 illustrates the implant of FIG. 1 positioned between two adjacent bones in the body.
FIG. 4 illustrates the implant of FIG. 1, with the lines indicating the degree of freedom of movement of the implant.
FIG. 5 depicts a perspective exploded view of another embodiment of the implant of the present invention.
FIG. 6 illustrates a cross section of the implant of FIG. 5 taken from the center through the bone engaging protrusion of the implant.
FIG. 7 depicts a perspective exploded view of a further embodiment of the implant of the present invention.
FIG. 8 illustrates a cross section of the implant of FIG. 7 taken from the center through the bone engaging protrusion of the implant.
〔発明を実施するための形態〕
以下の説明では、方向または配向のいずれの参照も、主として、かつ単に、例証の目的のために意図され、いかようにも、本発明の範囲の限定として意図されない。また、本明細書に説明される特定の実施形態は、本発明の制限としてみなされるものではない。
[Mode for Carrying Out the Invention]
In the following description, any reference to direction or orientation is intended primarily and merely for illustrative purposes and is not intended as a limitation on the scope of the invention in any way. In addition, the specific embodiments described herein are not to be considered as limiting the invention.
次に、図を参照すると、同様の参照番号は、同様の要素を指しており、図1および2は、可撓性コア200と、コア200の第1の係合表面204に接触するように動作可能である、第1の支持構成要素300と、コア200の反対の第2の係合表面208に接触するように動作可能である、第2の支持構成要素400とを含む、本発明による、移植片100を図示する。
Referring now to the drawings, like reference numerals refer to like elements, and FIGS. 1 and 2 contact the
図3を参照すると、移植片100は、例えば、椎骨10、12等の関節の隣接する骨間に位置付けられると、隣接する椎骨によって形成される関節を安定させるように動作可能である。移植片100はさらに、治療上の運動範囲を越える動きを制限しながら、関節の自然な運動学的動きを可能にする。一実施形態では、本運動範囲は、患者に対する完全に自然な運動学的特色を反映する。
With reference to FIG. 3, the
再び、図1および2を参照すると、可撓性コア200は、第1の区画202上に配置される、第1の係合表面204と、第2の区画206上に配置される、第2の係合表面208とを含む。図1および2に示される実施形態では、可撓性コア200は、より可撓性の折曲領域210を具備し、係合表面208に対して、係合表面204の変位または配向変更を可能にする。特に、第1の区画202は、一端が先細になり、折曲領域210を形成し、変形または座屈し、係合表面204、208の相対的角変位を可能にし得る。
Referring again to FIGS. 1 and 2, the
加えて、コア200は、第1および第2の係合表面204、208の部分間の距離を縮小するように圧縮してもよい。圧縮は、コア200の内部214に対して外向きに材料の拡張を含み、コア200の直径の増加をもたらしてもよく、またはコア200の材料は、コア200の内部に圧潰し、それによって、部分的にまたは完全に、コア200の外寸法を維持してもよい。代替として、コア200の材料内の空間は、サイズ減少されてもよく、例えば、コア200の材料の細胞質または多孔質母材によって形成される空間は、圧縮してもよく、それによって、コア200の外寸法の拡張が、維持または制限され得る。
In addition, the
第1の支持構成要素300は、コア係合表面304と、骨係合表面306とを有する、係合板302を含む。竜骨または他の突起308が、骨係合表面306から延在し、骨表面、例えば、椎骨10または12の内部部分に係合するように動作可能である。突起308は、骨内部成長のための領域を提供するように動作可能である、骨内部成長空間310を含み、さらに、板302が取着される骨との係合状態に板302を固着させる。
The
第2の支持構成要素400は、コア係合表面404と、骨係合表面406とを有する、係合板402を含む。竜骨、延在部、または突起408が、骨係合表面406から延在し、骨表面、例えば、椎骨10または12の内部部分に係合するように動作可能である。突起408は、骨内部成長のための領域を提供するように動作可能である、骨内部成長空間410を含み、さらに、板402が取着される骨と係合状態に板402を固着させる。
The
骨内部成長空間310、410はそれぞれ、有利にも、突起308、408挿入方向に対して、ある角度で形成され、それによって、潜在的に、骨内部成長が生じた後、骨から移植片100が分離する発生率を低減させ得る。
The
第1および第2の支持構成要素300、400のコア係合表面304、404は、有利にも、コア200に対する摺動または回転が意図される場合、コア200の係合表面204、208の表面材料に対して、潤滑材料で形成される。
The core engagement surfaces 304, 404 of the first and
図2は、加えて、コア200ならびに第1および第2の支持構成要素300、400の一方または両方の最大変位を制限するように動作可能である、テザー、すなわち、引綱218を図示する。引綱218は、コア200および支持構成要素300、400のうちの一方のいずれかのうちの2つ、または支持構成要素300、400の両方に添着される。引綱218は、本明細書に説明されるように、移植片100の意図される運動範囲内における動きを妨害しない、可撓性材料から形成され、有利にも、弾性材料から形成され、添着される要素の、進行の限界における、突然の相対的移動停止を回避してもよい。
FIG. 2 additionally illustrates a tether or
図1〜4の実施形態では、折曲領域210は、係合表面204に近接する点において、最も可撓性である。中空内部212が含まれてもよく、領域210を形成する材料が、係合表面208に対する係合表面204の変位の間、偏向し得る、空間を提供するように動作可能であってもよい。テザー218が提供され、第1および第2の支持構成要素300、400の最大運動範囲を制限するように動作可能であってもよい。本実施形態では、コア係合表面404は、平滑な表面を具備し、その上を可撓性コア200の第2の係合表面が、摺動し得る。コア係合表面404は、図4では、実質的に、平面として図示されるが、突起および陥凹が、図1および2に関して説明されるように、代替として、提供されてもよい。図示されないが、コア係合表面404から延在する、縁または***部分がさらに、または引綱218の代替として、コア係合表面404上の係合表面208の移動範囲を制限するように動作してもよい。
In the embodiment of FIGS. 1-4, the
図3および4を参照すると、骨10および12の相対移動は、移植片100が埋め込まれる、患者の動きから生じる。第1および第2の支持構成要素300、400は、それぞれ、骨10、12に取着されるため、対応する運動が、構成要素300、400内で誘発される。本発明によると、構成要素400は、骨10に接続されてもよく、構成要素300は、骨12に接続されてもよいことを理解されたい。すなわち、300または400のいずれかの構成要素は、他方に対して、上方に位置付けられ得る。
With reference to FIGS. 3 and 4, the relative movement of
患者の自然な体では、骨10および12は、6運動自由度に従って動く。これらの運動自由度はそれぞれ、図4に概略されるように、埋め込まれた移植片100によって可能とされる。具体的には、以下となる。
In the patient's natural body, the
(1)係合表面404に沿って摺動するコア200に対応する、線「X」によって示される方向における平行移動
(2)コア200の軸方向圧縮に対応する、線「Y」によって示される方向における平行移動
(3)係合表面404に沿って摺動するコア200に対応する、線「Z」によって示される方向における平行移動
(4)コア200の片側の圧縮に対応する、線「X」によって示される軸を中心とした回転
(5)係合表面404上を回転するコア200に対応する、線「Y」によって示される軸を中心とした回転
(6)コア200の片側の圧縮に対応する、線「Z」によって示される軸を中心とした回転
換言すると、移植片の軸が、本発明の移植片を通して、第1の隣接する骨から第2の隣接する骨に延在するように画定される場合、移植片は、以下に関して、第1および第2の隣接する骨の相対移動を可能にすることになる。
(1) Translation in the direction indicated by line “X” corresponding to
(a)軸を中心とした対向する回転
(b)軸方向屈曲
(c)軸方向圧縮
(d)軸に対する半径方向摺動
図5および6に示される代替実施形態では、コア200Aは、実質的に、隣接する区画202A、206Aより狭小である折曲領域210Aによって分離される、第1および第2の区画202A、206Aを含み、したがって、区画202A、206Aの角変位を可能にするように屈曲し、故に、係合表面204A、208Aの角度の相対的変位を可能にする。
(A) Opposing rotation about the axis (b) Axial bending (c) Axial compression (d) Radial sliding relative to the axis In the alternative embodiment shown in FIGS. 5 and 6, the
図6は、突起308および408を通して切り取られた、図5の移植片100の断面を図示する。コア係合表面404Aの少なくとも一部は、その上を可撓性コア200Aの第2の係合表面208Aの湾曲平滑表面の嵌合領域が、摺動し得る、湾曲平滑表面として構成される。例証では、コア係合表面404Aの湾曲摺動可能部分は、第2の支持構成要素400A内に陥凹され、係合表面208Aの嵌合摺動可能部分は、コア200Aから突出する。しかしながら、係合表面404Aが、突出されてもよく、係合表面208Aが、陥凹されてもよいことを理解されたい。
FIG. 6 illustrates a cross section of the
同様に、第1の係合表面204Aの一部は、その上をコア係合表面306Aの嵌合湾曲平滑表面が、摺動し得る、湾曲平滑表面である。図5〜6に示される実施形態では、コア200Aは、2つの凸状表面204A、208Aを形成し、所望の運動学的移動を助長し、予期される運動範囲を通して、所望の靭帯張力を維持し、骨の自然な静置位置を促進する。しかしながら、本発明によると、表面204Aまたは208Aのいずれかは、患者の治療上の必要性に応じて、凸状または凹状のいずれかであってもよいことを理解されたい。代替として、両表面は、前述の図1〜4または後述の図7〜8に図示されるように、平坦であってもよい。
Similarly, a portion of the
一実施形態では、突起312は、第1の係合表面306Aからコア開口または中空内部212A内に延在し、コア200に対して、第1の支持構成要素300の移動範囲を制限するように動作可能である。類似構成が、摺動可能に嵌合する係合表面404Aおよび208Aのために提供される可能性がある。
In one embodiment, the
本発明の実施形態は、それを通して、締結具が設置され、さらに、移植片100を患者内に固着させ得る、1つ以上の開口316、416を具備してもよい。例えば、骨ネジが、第1の支持構成要素300内の開口316を通して、骨10内に貫通されてもよく、別の骨ネジが、第2の支持構成要素400内の開口416を通して、骨12内に貫通されてもよい。骨成長剤が、代替として、または加えて、開口316または416内、あるいは骨係合表面306および/または406上に提供され、その中への骨の成長を促進してもよい。骨成長表面は、その中に組織が成長し、接着し得る、開口部または素地を具備してもよい。
Embodiments of the present invention may include one or
使用時、図5〜6の実施形態は、前述のように、全6運動自由度を可能にするが、しかしながら、嵌合湾曲摺動可能係合表面208Aおよび404Aのため、付加的方向安定性が提供され、それによって、摺動は、関節の撓曲または伸展を欠いた範囲に抑制される。本抑制は、嵌合湾曲係合表面208Aおよび404Aの自然な重力的静置状態から生じる。
In use, the embodiment of FIGS. 5-6, as described above, allows for a total of six degrees of freedom of movement, however, because of the mating curved
次に、図7〜8に図示される実施形態を参照すると、コア200Bは、第2の係合表面208Bに平坦表面を具備し、第2の支持構成要素400の平坦コア係合表面404Bに嵌合可能に接続可能である。本実施形態では、コア200Bは、それぞれ、コア200Bおよび第2の支持構成要素400B内に提供される、1つ以上のピンボアまたは開口216、416を通して貫通する、1つ以上のピン414によって、第2の係合表面404B上の回転に対して、コア200Bを添着するように構成される。ピンが図示されるが、当業者によって理解されるであろう、ネジ、接着剤、位置決めネジ、締まり嵌め、圧入、または他の方法を含む、他の締結具構成も可能であることを理解されたい。ピン414は、開口216または416内に螺入または圧入される、あるいは接着剤を使用して固着されてもよく、コア200Bまたは第2の支持構成要素400Bのいずれか一方また両方に固着されてもよい。
Referring now to the embodiment illustrated in FIGS. 7-8, the
ピン414は、回転を防止し、かつコア200Bを係合表面404B上のある位置に維持するために利用され得るが、係合表面404Bに対するコア200Bの軸方向位置は、代替として、または追加として、コア200Bおよびコア係合表面404Bのそれぞれの陥凹部分220と突出部分420との間のスナップ嵌着係合によって維持されてもよい。代替として、コア200Bは、突出部分を具備してもよく、コア係合表面404Bは、嵌合陥凹を具備してもよい。
Pin 414 can be utilized to prevent rotation and maintain core 200B in a position on
本発明の実施形態のいずれかでは、コア200、200A、200Bに対して、コア係合表面304、304A、304Bおよび404、404A、404Bの一方または両方の位置を維持することが所望される場合、ピン、スナップ嵌着、または他の締結具が、前述のように、使用されてもよい。
In any of the embodiments of the present invention, where it is desired to maintain the position of one or both of the core engagement surfaces 304, 304A, 304B and 404, 404A, 404B relative to the
図8をさらに参照すると、コア係合表面304Bは、第1の係合表面204Bの湾曲部分より大きい半径を有する、湾曲部分を有することが分かる。したがって、コア係合表面304Bおよび第1の係合表面204Bは、その個別の曲率間の差異によって影響されるため、相互に対して、制限された範囲まで、容易に摺動し得る。コア200Bはまた、本発明の他の実施形態に関して、本明細書のいずれかで詳述されるように、回転され、均等にまた側方に圧縮されてもよい。
With further reference to FIG. 8, it can be seen that the
構成要素の上方および下方位置は、図示されるように、本発明の理解における読者の便宜性のためであって、移植片100は、患者の利点に応じて、示されるものと逆配向で埋め込まれてもよいことを理解されたい。
The upper and lower positions of the components, as shown, are for the convenience of the reader in understanding the present invention, and the
使用時、図7〜8の実施形態は、前述のように、全6運動自由度を可能にするが、しかしながら、嵌合湾曲摺動可能係合表面204Bおよび304Bのため、付加的方向安定性が提供され、それによって、摺動は、関節の撓曲または伸展を欠いた範囲に抑制される。本抑制は、嵌合湾曲係合表面204Bおよび304Bの自然な重力的静置状態から生じる。骨12に対する骨10の回転、すなわち、枢動は、第2の係合表面208Bが、コア係合表面404Bに対して添着されるため、第1の係合表面204Bとコア係合表面304Bとの間の界面を通してのみ、伝達される。同様に、摺動は、同一理由から、本界面を通してのみ、行われる。表面208Bおよび404Bは、代替として、他の実施形態に関して本明細書に詳述されるように、相互に対して摺動してもよい。
In use, the embodiment of FIGS. 7-8, as described above, allows for a total of six degrees of freedom of movement, however, because of the mating curved slidable engagement surfaces 204B and 304B, additional directional stability. , Whereby sliding is constrained to a range lacking joint flexion or extension. This suppression results from the natural gravitational rest of the mating curved engagement surfaces 204B and 304B. The rotation, or pivoting, of the
嵌合表面204、204A、204Bと304、304A、304Bと、または208、208A、208Bと404、404A、404Bとは、例えば、凹状、凸状、半球状、楕円形、複合体、または樽状形状であってもよく、それによって、摺動、枢動、回転、揺動、または他の相対移動に対する抵抗は、全方向において均一であっても、または特定の方向において異なってもよい。 The mating surfaces 204, 204A, 204B and 304, 304A, 304B or 208, 208A, 208B and 404, 404A, 404B are, for example, concave, convex, hemispherical, elliptical, composite, or barrel-shaped It may be shaped so that the resistance to sliding, pivoting, rotating, swinging, or other relative movement may be uniform in all directions or different in a particular direction.
図8はさらに、第1および第2の支持構成要素300B、400B内の挿入ツールチャネル、ボア、開口部、または開口218、418を図示する。移植片100は、靭帯によって離間された関係に維持される、関節表面間に挿入されるため、関節内への挿入に先立って、移植片100を機械的に圧縮する必要があり得る。図示されないが、当技術分野において公知のようなツールは、ツール開口218、418に係合する、尖叉を具備してもよく、それに応じて、第1および第2の支持構成要素300B、400Bは、埋込の間、施術者によって決定されるように、ともに移動されてもよく、または引き離されてもよい。さらに、移植片100は、前方、前側方、または側方アプローチを通して埋め込まれてもよく、故に、ツール開口218、418は、埋込の間、移植片100を機械的に把持し、操作するための手段を提供する。
FIG. 8 further illustrates insertion tool channels, bores, openings, or
本発明は、例えば、頸椎椎間板置換術の置換または安定化のために、関節置換術用移植片を提供するが、他の関節、例えば、指、手、手首、肘、肩、脊椎の他の区域、腰、膝、足首、足、または足指の1つ以上の関節が、部分的にまたは完全に、移植片100によって、置換されてもよい。
The present invention provides joint replacement implants for replacement or stabilization of, for example, cervical disc replacement, but other joints such as fingers, hands, wrists, elbows, shoulders, other spines One or more joints of the area, waist, knee, ankle, foot, or toe may be partially or completely replaced by the
移植片100は、特に、椎間板に関するが、上記に詳細されるように、全6運動自由度において、移動を呈する、全関節に関して、自然な運動学的特色および自然な関節特性を復元するように動作可能である。
The
移植片100の全要素は、可撓性材料から作製され得るが、コア200は、特に、第1および第2の支持構成要素300、400の角変位に対応するために撓曲する。関節は、撓曲または伸展されるため、コア200の可撓性および/または弾性材料は、膨隆または伸張し、第1および第2の係合表面204、208の角変位を可能にし得る。加えて、または代替として、折曲領域210は、厚さおよび/または形状を通して、コア200の屈曲を容易にするように適合される、コア200の比較的により脆弱な領域を提供する。
Although all elements of the
移植片100は、デバイスが移植されているべきである期間の間、患者のために、十分な強度、可撓性、弾性、および耐久性を有する、当業者に公知の任意の生体適合性材料を使用して組み立てられてもよい。実施例として、金属、例えば、チタンおよびクロム合金、ポリマー、例えば、PEEKまたは高分子量ポリエチレン(HMWPE)、ならびにセラミックが挙げられるが、それらに限定されない。
The
移植片の一部または全部は、放射線不透過性または放射線透過性であってもよく、あるいはそのような特性を有する材料が、移植片に添加される、または組み込まれ、埋込の間およびその後、デバイスの撮像を改善してもよい。 Part or all of the implant may be radiopaque or radiolucent, or a material having such properties is added or incorporated into the implant, during and after implantation. , Device imaging may be improved.
コア係合表面304、304A、304B、404、404A、404B、ならびに第1および第2の係合表面204、204A、204Bおよび208、208A、208Bを含む、回転、枢動、または摺動する、対向する嵌合表面は、同一または異なる材料から作製されてもよく、その組み合わせは、治療的運動円滑性または所望の抗力をもたらす。移植片100の表面は、例えば、チタンプラズマスプレーによって、プラズマ噴霧されてもよく、およびビーズブラスト処理または電解研磨されてもよい。
Rotating, pivoting, or sliding, including the
より具体的には、支持構成要素は、ASTM F1537(および、ISO 5832−12)に規定されるように、コバルト−クロム−モリブデン合金(Co−Cr−Mo)から製造されてもよい。平滑な表面は、ASTM F1580、F1978、F1147、およびC−633(および、ISO 5832−2)に規定されるように、市販の純チタンでプラズマ噴霧されてもよい。コアは、ASTM F648(および、ISO 5834−2)に規定されるように、超高分子量ポリエチレン(UHMWPE)から製造されてもよい。 More specifically, the support component may be made from a cobalt-chromium-molybdenum alloy (Co—Cr—Mo) as specified in ASTM F1537 (and ISO 5832-12). The smooth surface may be plasma atomized with commercially pure titanium as defined in ASTM F1580, F1978, F1147, and C-633 (and ISO 5832-2). The core may be made from ultra high molecular weight polyethylene (UHMWPE) as defined in ASTM F648 (and ISO 5834-2).
コア200、200A、200Bは、代替として、一実施形態では、ポリカーボネートウレタン(PCU)、または熱可塑性ポリカーボネートウレタン(TPU)、例えば、水酸基末端ポリカーボネート、芳香族ジイソシアネート、および鎖延長剤として使用される低分子量グリコールの反応生成物として形成される熱可塑性エラストマーに関しては、DSM IP Assets B.V.Corporation(Heerlen Netherlands)の登録商標であるBionateを使用して加工されてもよい。当業者によって理解されるように、好適な可撓性、耐久性、および生体適合性を伴う他のポリマー材料もまた、使用されてもよい。
The
本発明によると、種々のサイズの移植片が、患者の生体構造に最良に適合するように提供されてもよい。一致または不一致サイズの支持構成要素およびコアが、患者の治療上の必要性に最も一致するように、医療施術者によって、埋込手技の間に組み立てられてもよく、アセンブリは、挿入ツールを使用して体内に挿入される。本発明の移植片はまた、全体的に角度のある幾何学形状、例えば、支持構成要素およびコアの角度のある嵌合配置を具備し、頸椎用途に対して、例えば、0°から6°の自然な脊柱前弯症、すなわち、矯正するための脊柱前弯症を提供してもよいが、全く異なる値が、他の関節には有利である場合がある。例えば、頸椎内で使用するための移植片の高さは、典型的には、7mmから12mmの範囲であり得るが、サイズは、本発明の移植片が埋め込まれるべき患者および関節に依存する。 According to the present invention, various sized implants may be provided to best fit the patient's anatomy. Matching or mismatched size support components and cores may be assembled during the implantation procedure by the medical practitioner so that they best match the patient's therapeutic needs, and the assembly uses an insertion tool And inserted into the body. The implant of the present invention also comprises an overall angular geometry, such as an angular mating arrangement of the support component and the core, for example 0 ° to 6 ° for cervical spine applications. Natural lordosis, ie, lordosis to correct, may be provided, but completely different values may be advantageous for other joints. For example, the height of the implant for use in the cervical spine can typically range from 7 mm to 12 mm, but the size depends on the patient and joint to which the inventive implant is to be implanted.
本発明によると、単一移植片100を使用して、弱化した関節または関節部分に安定化を提供してもよい。代替として、2つ、3つ、またはそれ以上の移植片100が、単一関節レベルにおいて、または複数の関節内で使用されてもよい。さらに、移植片100は、他の安定手段と組み合わせられてもよい。
In accordance with the present invention, a
加えて、移植片100は、治療上有利な時間間隔の間、体内で生物分解する材料を使用して組み立てられてもよい。さらに、移植片100は、有利にも、平滑かつ/または丸い外部表面を具備し、近隣組織に及ぼす有害な機械的影響の潜在性を低減させる。
In addition, the
本発明の任意の表面または構成要素は、当業者に公知の方法を使用して、治療的割合において放出され得る、骨成長、治癒、抗菌性、または薬物材料を含む、治療薬でコーティングされる、あるいはそれによって含浸されてもよい。 Any surface or component of the present invention is coated with a therapeutic agent, including bone growth, healing, antibacterial, or drug material that can be released in therapeutic proportions using methods known to those skilled in the art. Or may be impregnated thereby.
本発明は、特に、上記の本明細書で図示および説明されるものに限定されないことは、当業者によって理解されるであろう。加えて、それとは反対であることが上記で記載されない限り、付随の図面はすべて、正確な縮尺であるわけではないことに留意されたい。種々の修正および変形例は、本発明の範囲および精神から逸脱することなく、前述の教示に照らして可能である。 It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, it should be noted that not all of the accompanying drawings are to scale unless otherwise stated to the contrary. Various modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention.
本明細書に列挙された参考文献はすべて、その全体として、参照することによって明示的に組み込まれる。加えて、それとは反対であることが上記で記載されない限り、付随の図面はすべて、正確な縮尺であるわけではないことに留意されたい。本発明に対して、多くの異なる特徴が存在し、これらの特徴は、ともに、または別個に、使用されてもよいことが想定される。したがって、本発明は、特徴の任意の特定の組み合わせまたは本発明の特定の用途に限定されるべきではない。さらに、本発明の精神および範囲内の変形例および修正が、本発明に関わる当業者に想起され得ることを理解されたい。故に、本発明の範囲および精神内にある、本明細書に記載される本開示から当業者によって容易に達成可能な便宜上の修正はすべて、本発明のさらなる実施形態として含まれるものとする。 All references listed herein are expressly incorporated by reference in their entirety. In addition, it should be noted that not all of the accompanying drawings are to scale unless otherwise stated to the contrary. There are many different features for the present invention, and it is envisioned that these features may be used together or separately. Thus, the present invention should not be limited to any specific combination of features or specific applications of the present invention. In addition, it should be understood that variations and modifications within the spirit and scope of the invention may occur to those skilled in the art to which the invention pertains. Accordingly, all convenient modifications readily within the scope and spirit of the present invention that are readily achievable by those skilled in the art from the present disclosure as described herein are intended to be included as further embodiments of the present invention.
Claims (16)
前記患者の前記第1の骨に添着されるように適合される、第1の側と、平滑な表面を有する、前記第1の側と反対の第2の側と、を有する、第1の支持構成要素と、
平滑な表面を有する第3の側を有し、前記第2の側と嵌合摺動可能係合状態に位置付け可能である、弾性コアであって、前記第3の側と反対の第4の側をさらに含み、前記コアの直径の増加を引き起こす拡張をもたらす圧縮性がある、弾性コアと、
前記第4の側と嵌合可能な第5の側と、前記患者の前記第2の骨に添着されるように適合される、前記第5の側と反対の第6の側と、を有する、第2の支持構成要素と、を備え、
前記移植片の軸は、前記移植片を通して、前記第1の隣接する骨から前記第2の隣接する骨に延在するように画定され、
前記コアは、前記第1の支持構成要素と第2の支持構成要素との間に位置付け可能であって、それによって、前記第1の隣接する骨と第2の隣接する骨との間に位置付け可能であって、
前記コアは、前記軸に沿って、相対的第1の距離において、前記第1および第2の支持のそれぞれの少なくとも一部を分離し、前記コアは、圧力下、弾性的に変形可能であって、前記軸に沿って、第2のより少ない相対的距離において、前記第1および第2の支持のそれぞれの少なくとも一部を分離し、
前記コアは、前記第2の側と係合状態において、前記軸に対して半径方向に、前記第3の側上を摺動してもよく、
前記第1の支持構成要素が、前記第1の隣接する骨に添着され、前記第2の支持構成要素が、前記第2の隣接する骨に添着され、前記コアが、前記第1の支持構成要素と第2の支持構成要素との間に位置付けられると、前記第1および第2の隣接する骨は、安定し、前記コアは、別個にまたは同時に、弾性的に変形および摺動して、前記骨の自然な運動学的移動と同様に、前記2つの隣接する骨の運動学的移動を可能にする場合があり、
前記第1の支持構成要素の前記第2の側は、前記第2の側に接触する前記弾性コアの前記第3の側の半径より大きい半径がある接触表面を有しており、
前記コアは、陥凹部分と突出部分とをさらに含み、
前記陥凹部分および前記突出部分は前記コアの外周の周囲に延在し、前記コアの前記突出部分はスナップ嵌着接続を通して前記第2の支持構成要素の対応する嵌合機構に連結するように構成されており、
少なくとも1つのピンが、前記第2の支持構成要素と前記コアとを一緒に係止するように、前記第2の支持構成要素を通して延在し、前記コアの前記陥凹部分の少なくとも一部分に挿入する、移植片。 An implant for stabilizing first and second adjacent bones in a patient comprising:
A first side adapted to be affixed to the first bone of the patient; and a second side opposite the first side having a smooth surface. A supporting component;
An elastic core having a third side having a smooth surface and capable of being fitted and slidably engaged with the second side, wherein the fourth side is opposite the third side; An elastic core that further includes a side and is compressible to provide expansion that causes an increase in the diameter of the core;
A fifth side matable with the fourth side, and a sixth side opposite the fifth side, adapted to be attached to the second bone of the patient. A second support component;
The graft axis is defined to extend through the graft from the first adjacent bone to the second adjacent bone;
The core is positionable between the first support component and the second support component, thereby positioning between the first adjacent bone and a second adjacent bone. Is possible,
The core separates at least a portion of each of the first and second supports at a relative first distance along the axis, the core being elastically deformable under pressure. Separating at least a portion of each of the first and second supports at a second less relative distance along the axis,
The core may slide on the third side in a radial direction relative to the axis in engagement with the second side;
The first support component is affixed to the first adjacent bone, the second support component is affixed to the second adjacent bone, and the core is the first support configuration When positioned between an element and a second support component, the first and second adjacent bones are stable and the core is elastically deformed and slid separately or simultaneously, Like the natural kinematic movement of the bone, it may allow kinematic movement of the two adjacent bones;
The second side of the first support component has a contact surface with a radius greater than the radius of the third side of the elastic core that contacts the second side;
The core further includes a recessed portion and a protruding portion,
The recessed portion and the protruding portion extend around an outer periphery of the core, and the protruding portion of the core is coupled to a corresponding fitting mechanism of the second support component through a snap-fit connection. Configured,
At least one pin extends through the second support component and inserts into at least a portion of the recessed portion of the core to lock the second support component and the core together. To the graft.
(a)前記軸を中心とした対向する回転、
(b)軸方向屈曲、
(c)軸方向圧縮、および
(d)前記軸に対する半径方向摺動
に関して、前記第1および第2の隣接する骨の相対運動を可能にする、請求項1に記載の移植片。 The graft is
(A) opposite rotation about the axis;
(B) axial bending,
The implant according to claim 1, enabling relative movement of the first and second adjacent bones with respect to (c) axial compression and (d) radial sliding relative to the axis.
前記患者の前記第1の骨に添着されるように適合される、第1の側と、平滑な凹状また凸状表面を有する、前記第1の側と反対の第2の側と、を有する第1の支持構成要素であって、第1の支持構成要素から延在する竜骨を含み、前記竜骨の後方の最も大きい区画には延在した竜骨を通す開口部を有する、第1の支持構成要素と、
前記第2の側が凸状表面を有する場合に平滑な凹状表面を有し、前記第2の側が凹状表面を有する場合に平滑な凸状表面を有する第3の側を有し、前記第3の側はそれによって前記第2の側と嵌合摺動可能係合に位置付け可能である、弾性コアであって、前記第3の側と反対の第4の側をさらに含む、弾性コアと、
前記第4の側と嵌合可能な第5の側と、前記患者の前記第2の骨に添着されるように適合される、前記第5の側と反対の第6の側と、を有する、第2の支持構成要素と、を備え、
前記移植片の軸は、前記移植片を通して、前記第1の隣接する骨から前記第2の隣接する骨に延在するように画定され、
前記コアは、前記第1の支持構成要素と第2の支持構成要素との間に位置付け可能であって、それによって、前記第1の隣接する骨と第2の隣接する骨との間に位置付け可能であって、
前記コアは、前記軸に沿って、相対的第1の距離において、前記第1および第2の支持のそれぞれの少なくとも一部を分離し、前記コアは、圧力下、弾性的に変形可能であって、前記軸に沿って、第2のより少ない相対的距離において、前記第1および第2の支持のそれぞれの少なくとも一部を分離し、
前記コアは、前記第2の側と係合した状態において、前記軸に対して、半径方向に、前記第3の側上を摺動してもよく、
前記第1の支持構成要素は、前記第2の支持構成要素に対して、前記軸を中心として、回転可能であって、
前記第1の支持構成要素が、前記第1の隣接する骨に添着され、前記第2の支持構成要素が、前記第2の隣接する骨に添着され、前記コアが、前記第1の支持構成要素と第2の支持構成要素との間に位置付けられると、前記第1および第2の隣接する骨は、安定し、前記コアは、別個にまたは同時に、弾性的に変形、回転、および摺動し、前記骨の自然な運動学的移動と同様に、前記2つの隣接する骨の運動学的移動を可能にし得、
前記第1の支持構成要素の前記第2の側は、前記第2の側に接触する前記弾性コアの前記第3の側の半径より大きい半径がある接触表面を有しており、
前記コアは、陥凹部分と突出部分とをさらに含み、
前記陥凹部分および前記突出部分は前記コアの外周の周囲に延在し、前記コアの前記突出部分はスナップ嵌着接続を通して前記第2の支持構成要素の対応する嵌合機構に連結するように構成されており、
少なくとも1つのピンが、前記第2の支持構成要素と前記コアとを一緒に係止するように、前記第2の支持構成要素を通して延在し、前記コアの前記陥凹部分の少なくとも一部分に挿入する、移植片。 An implant for stabilizing first and second adjacent bones in a patient comprising:
A first side adapted to be affixed to the first bone of the patient; and a second side opposite the first side having a smooth concave or convex surface. A first support component comprising a keel extending from the first support component, the largest compartment behind the keel having an opening through which the extended keel passes Elements and
Having a smooth concave surface when the second side has a convex surface, and having a third side having a smooth convex surface when the second side has a concave surface; An elastic core, further comprising a fourth side opposite the third side, the side being positionable in mating slidable engagement with the second side;
A fifth side matable with the fourth side, and a sixth side opposite the fifth side, adapted to be attached to the second bone of the patient. A second support component;
The graft axis is defined to extend through the graft from the first adjacent bone to the second adjacent bone;
The core is positionable between the first support component and the second support component, thereby positioning between the first adjacent bone and a second adjacent bone. Is possible,
The core separates at least a portion of each of the first and second supports at a relative first distance along the axis, the core being elastically deformable under pressure. Separating at least a portion of each of the first and second supports at a second less relative distance along the axis,
The core may slide on the third side in a radial direction with respect to the shaft in a state engaged with the second side,
The first support component is rotatable relative to the second support component about the axis;
The first support component is affixed to the first adjacent bone, the second support component is affixed to the second adjacent bone, and the core is the first support configuration When positioned between an element and a second support component, the first and second adjacent bones are stable and the core is elastically deformed, rotated, and slid separately or simultaneously. And allows the kinematic movement of the two adjacent bones, as well as the natural kinematic movement of the bone,
The second side of the first support component has a contact surface with a radius greater than the radius of the third side of the elastic core that contacts the second side;
The core further includes a recessed portion and a protruding portion,
The recessed portion and the protruding portion extend around an outer periphery of the core, and the protruding portion of the core is coupled to a corresponding fitting mechanism of the second support component through a snap-fit connection. Configured,
At least one pin extends through the second support component and inserts into at least a portion of the recessed portion of the core to lock the second support component and the core together. To the graft.
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US10687958B2 (en) | 2020-06-23 |
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US20220273457A1 (en) | 2022-09-01 |
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